Short Bowel Syndrome (SBS) MedDRA version: 18.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: ZP1848
Pharmaceutical Form: Solution for injection
CAS Number: None
Current Sponsor code: ZP1848
Other descriptive name: ZP1848
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
Zealand Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out. 2. Age 18 years and 90 years 3. Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago 4. A stable PS volume ( =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 8. Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator 11. Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator. 12. Crohn’s disease patients not being in clinical remission for the last 12 weeks prior to randomization 13. Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening 15. History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded) 20. eGFR (by the MDRD formula) <30 mL/min/1.73 m2 21. Clinically meaningful renal disease as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effect of three different doses of ZP1848 on intestinal absorption in SBS patients after three week treatment periods.;Secondary Objective: Secondary Objectives • To evaluate the efficacy of three different doses of ZP1848 on other functional parameters than those covered in the primary objective after three week treatment periods. • To describe safety and tolerability of three different doses of ZP1848 during and after three week treatment periods. • To describe the pharmacokinetics of three different doses of ZP1848 during and after three week treatment periods. • To describe the pharmacodynamics of three different doses of ZP1848 during and after three week treatment periods. • To describe the immunogenicity of ZP1848.;Primary end point(s): The primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods, where: •The baseline values are measured as the average of the 72h baseline balance studies before each treatment period, and •The end of three week treatment period values are measured as the average of the 72h treatment balance studies at the end of each treatment period Each patient is therefore planned to deliver two values for the primary endpoint; one value for each of the two planned treatment periods. ;Timepoint(s) of evaluation of this end point: From baseline balance study to end of 3 weeks treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints Efficacy 1.Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods 2.Absolute and relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods 3.Absolute and relative change from baseline to the end of treatment of wet weight absorption (measured by oral intake minus fecal excretion) measured separately over each of the two treatment periods 4.Absolute and relative change from baseline to end of treatment of urine weight minus oral intake, measured separately over each of the two treatment periods 5.Absolute and relative change from baseline to the end of treatment of the intestinal absorption (oral intake minus fecal excretion) of electrolytes measured separately over each of the two treatment periods -Sodium -Magnesium -Calcium -Potassium 6.Absolute and relative change from baseline to the end of treatment of the intestinal absorption (oral intake minus fecal excretion) of macronutrients measured separately over each of the two treatment periods -Energy assessed by bomb calorimetry -Lipids -Nitrogen -Carbohydrates 7.Change in patient reported outcomes (SF-36, SBS-QoL, VAS scales) 8.Incidence of adverse events 9. Incidence of anti-drug antibodies;Timepoint(s) of evaluation of this end point: 1-7 From baseline balance study to end of three weeks treatment period. 8-9 Up to day 109 | — |
Countries
Denmark
Contacts
Public ContactVicky Lüth Bjerre
Regulatory Affairs/ Zealand Pharma A/S
Outcome results
None listed